BEUDAMED
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    Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Bernafon

    FDA UDI
    Bernafon AG·05711584114926·CZ7 MNR, 2.4G NFM SABE/MSIL CORAL 7 GPL

    REPROCESSED SOFT TISSUE ABLATORS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VSI GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRSVN ALLPOLY TIB LMRL S2 7MM

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code HRY·October 24, 2008

    UNKNOWN DEEP BRAIN STIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·August 11, 2011

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 9, 2013

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023